What does CEyoo do?
CEyoo takes over the regulatory tasks and responsibilities of a manufacturer for you in terms of the EU-Regulation 2017/745 (MDR) or 2017/746 (IVDR). This includes the efficient planning, implementation and documentation of quality management, product certification and market surveillance for your medical devices/IVD.For non-EU manufacturers, Ceyoo offers the service as a European Authorized Representative (EU-REP) according to MDR/IVDR Art. 11 and thus takes over your regulatory tasks and responsibilities in the EU.
Why CEyoo?
Regulatory affairs, quality management and market surveillance processes related to the marketing of medical devices and in vitro diagnostics (IVD) take up a tremendous amount of resources in most companies.To your economic advantage, CEyoo takes on (temporary) manufacturer responsibility, provides the process framework and capacities for a functioning quality management system (QMS) and takes care of professional market surveillance. By the way, this is in the benefit of the Notified Bodies: Professionalism facilitates and accelerates the approval procedure, and your medical device or IVD is on the market faster.If you wish, we will bring you up to our level of knowledge. This puts you in a position to assume manufacturer responsibility for your product yourself at a fixed point in time.
How does CEyoo benefit you?
Any company that wants to handle its regulatory affairs processes more efficiently benefits from CEyoo as a legal manufacturer. Primarily companies with a small product portfolio, such as start-ups, as well as companies that buy a start-up. Why? The effort required to place a single medical device on the market is extremely high: a QMS must be set up and maintained. The same applies to measures and processes for mandatory post-market surveillance (PMS).
In addition, our offer is aimed at all companies that would like to consolidate their product portfolio after the implementation of the QMS from MDD/IVDD to MDR/IVDR without having to conduct a face-out. Or who are unable to do so for a variety of reasons. In order to remain marketable, the cooperation with CEyoo can be the saving anchor.
If you are planning your medical devices and/or IVDs to enter the European market, CEyoo can take over the regulatory tasks for you as an EU authorized representative (EC-REP). In this way, you can concentrate fully on the distribution of your medical devices/IVDs.
In addition, our offer is aimed at all companies that would like to consolidate their product portfolio after the implementation of the QMS from MDD/IVDD to MDR/IVDR without having to conduct a face-out. Or who are unable to do so for a variety of reasons. In order to remain marketable, the cooperation with CEyoo can be the saving anchor.
If you are planning your medical devices and/or IVDs to enter the European market, CEyoo can take over the regulatory tasks for you as an EU authorized representative (EC-REP). In this way, you can concentrate fully on the distribution of your medical devices/IVDs.
Who is CEyoo?
Behind CEyoo are more than 60 bright minds and 25 years of experience in the areas of documentation, quality management systems, market access and post-market surveillance (PMS): CEyoo is a subsidiary of Metecon GmbH in Mannheim. For you as a client, this means that you always have project-experienced contact persons who have in-depth and wide-ranging expertise.